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WASHINGTON– In yet another problem for Johnson & & Johnson’s coronavirus vaccine, the Food and Drug Administration on Thursday restricted its usage to grownups who can not or refuse to get the Pfizer-BioNTech or Moderna vaccines, pointing out safety concerns.

The agency stated 60 cases of a severe but unusual blood-clotting disorder have actually been identified, including 9 deaths, out of about 18 million doses administered. The action comes about 5 months after the Centers for Disease Control and Prevention suggested Moderna’s and Pfizer’s vaccines over Johnson & & Johnson’s for booster shots.

The F.D.A. said that weighing the threats of Johnson & & Johnson’s vaccine versus the advantages, it had chosen to restrict its usage to grownups who can not access Pfizer’s or Moderna’s vaccines, or for whom those shots are not “clinically proper.” One example would be individuals who experienced an extreme allergy to the other 2 vaccines, the agency said.

It said the vaccine could likewise be provided to adults who “would otherwise not get a Covid-19 vaccine.”

Johnson & & Johnson was eclipsed long ago by Pfizer and Moderna in the country’s vaccination project; federal authorities have stated the mRNA vaccines produced by those companies are both more secure and more effective. In a statement, Johnson & & Johnson stated the F.D.A.’s action reflected the already-known risk of the negative effects, not new information on the rate at which it takes place. In an indication of the company’s own flagging interest in its vaccine, it has stopped supplying sales outlooks for the shot to investors.

Reports that the vaccine can activate a condition referred to as thrombosis with thrombocytopenia syndrome have actually bedeviled it from early on. In April 2021, not long after it was approved for emergency usage, federal authorities paused circulation of the vaccine for a safety evaluation. Regulators lifted the pause 10 days later on but included a warning to directions for its usage.

In December, the C.D.C. recommended that adults seeking a booster shot choose Moderna or Pfizer rather of Johnson & & Johnson, pointing out more advantages and lower dangers. Paired with a host of manufacturing difficulties in the United States, some specialists stated, the company’s judgment showed that the federal government had actually all however crossed out Johnson & & Johnson’s vaccine.

According to the F.D.A. statement on Thursday, federal authorities now have 60 reports of the blood-clotting condition– or four times as many as were reported when in 2015’s pause in circulation was lifted. In the interim, the number of Johnson & & Johnson doses administered has a little more than doubled, while the variety of Pfizer and Moderna receivers has increased.

The variety of deaths credited to the disorder set off by the Johnson & & Johnson’s vaccine does not appear to have increased much, if at all. But there have been far less, if any, presumed deaths due to negative effects from the mRNA vaccines, federal health officials have said.

In its announcement, the F.D.A. mentioned more than 6 cases and near one death attributed to the blood-clotting disorder for every single 2 million shots of Johnson & & Johnson vaccine administered in the United States.

About 17 million Americans have actually now gotten one dosage of Johnson & & Johnson’s vaccine, and another 1.5 million have gotten a booster dose, according to the C.D.C.’s information. By comparison, more than 200 million Americans have actually gotten at least 2 doses of either Moderna’s or Pfizer’s vaccine.

Attempting to cast the tight brand-new limitations in a positive light, Johnson & & Johnson stated: “Data continue to support a beneficial benefit-risk profile for the Johnson & & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”